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The intended use of the Acutron Mentor is for relief of chronic intractable pain, some types of acute pain, and postoperative pain. It is applicable for a wide range of patients with pain, except those for which its use if contraindications for use are reproduced in the 510K submission K981976 in Section 11.0, preface pages 1 - 2. These include contraindications or cautions for patients with cardiac pacemakers, who are pregnant, are using electronic monitoring equipment, or with sensitive skin. It is also vital to obtain an accurate diagnosis of the cause of a patient's pain concurrent with TENS device use so that the overall condition can be addressed.

Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

The Acutron Mentor is an electromedical device of advanced design that is capable of delivering precisely modulated currents of variable intensity, frequency, polarity, modulation and waveform configuration to the soft tissues and peripheral nerves of the body via transcutaneous stimulation. The Acutron uses a large, easy to read LCD screen for all treatment set-up and monitoring, which greatly speeds and simplifies usage. The Acutron has four independently controlled and electrically isolated output channels. The multiple outputs and variations of current configuration allow the user many invaluable options of affording comfortable and effective treatment to his or her patients. These are: Conventional pulsed milliamp stimulator, Advanced microcurrent stimulator, Interferential stimulator with classic milliamp and microcurrent options, Russian current stimulator with fixed 2500 Hz carrier frequency with 50 Hz bursts.

This document is a 510(k) premarket notification for the Acutron Mentor TENS device. It primarily focuses on demonstrating substantial equivalence to predicate devices and outlining the device's technical characteristics and intended use. It does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth, their qualifications, or adjudication method for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Sample size for the training set or how ground truth was established for the training set.

The document does provide:

1. Device Description and Intended Use:

• Commercial name: Acutron Mentor
• Device Classification: TENS device (transcutaneous electric nerve stimulator)
• Intended Use: For relief of chronic intractable pain, some types of acute pain, and postoperative pain.
• Key Features: Delivers precisely modulated currents of variable intensity, frequency, polarity, modulation, and waveform configuration. Has four independently controlled and electrically isolated output channels, LCD screen, two current ranges (milliamp and microamp), treatment timer per channel, conductivity test mode. Offers probe and pad electrodes.

2. Legal Marketing and Predicate Devices:

• Acutron Multiwave 911E (K880042B)
• Theratouch 4.7 (K932868)
• Dynatron 550 (K941577)

3. Comparison of Technological Characteristics (Similarities and Differences to Old Acutron Model):

• Similarities: Combination of digital and analog design, double-sided PC boards, four isolated output channels, ability to switch between milliamp and microamp outputs, conductivity monitoring, user modification of waveform/polarity/intensity/modulation/time, rechargeable battery, similar output circuit components, two types of electrodes.
• Differences (New vs. Old):
  • Chassis: New- molded ABS plastic vs. Old- Metal.
  • User Interface: New- buttons around LCD and Command Knob vs. Old- manual knobs and switches.
  • Power Supply: New- External AC/DC adapter powers PCB and trickle charges backup battery vs. Old- external charger for two rechargeable batteries, unit ran only off batteries. (New unit is claimed to be at least as safe, probably more so, due to double fusing, transformer isolation, double sense resistors, and current limiting surge protection).
  • Output Currents: New unit offers additional waveforms and modulations, notably sine wave milliamperage in 2500 Hz (Russian stimulation) and 4000 Hz (interferential currents) ranges.
  • Programmability: New- user can preprogram up to 40 sets of treatment parameters vs. Old- one "basic" set.
  • Output Channels: New- Probe output on channel D, all four channels can be used for pad output vs. Old- three channels for pad, one for probe only.

Conclusion:

This document serves as a regulatory submission (510(k)) to demonstrate the substantial equivalence of the Acutron Mentor to previously cleared devices, primarily based on technological characteristics and intended use. It does not detail specific performance studies with acceptance criteria, test sets, or expert evaluations that would typically be associated with proving clinical efficacy or diagnostic accuracy. Such studies are generally not required for 510(k) submissions where substantial equivalence can be demonstrated through other means, like technological comparison to predicate devices.

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